Improving the laboratory result release process in the light of ISO 15189:2012 standard

. 2021 Nov ; 522 () : 167-173. [epub] 20210818

Jazyk angličtina Země Nizozemsko Médium print-electronic

Typ dokumentu časopisecké články

Perzistentní odkaz   https://www.medvik.cz/link/pmid34418364
Odkazy

PubMed 34418364
DOI 10.1016/j.cca.2021.08.013
PII: S0009-8981(21)00291-6
Knihovny.cz E-zdroje

The ISO 15189:2012 standard section 5.9.1 requires laboratories to review results before release, considering quality control, previous results, and clinical information, if any, and to issue documented procedures about it. While laboratory result reporting is generally regarded as part of the post-analytical phase, the result release process requires a general view of the total examination process. Reviewing test results may follow with troubleshooting and test repetition, including reanalyzing an individual sample or resampling. A systematic understanding of the result release may help laboratory professionals carry out appropriate test repetition and ensure the plausibility of laboratory results. In this paper, we addressed the crucial steps in the result release process, including evaluation of sample quality, critical result notification, result reporting, and recommendations for the management of the result release, considering quality control alerts, instrument flags, warning messages, and interference indexes. Error detection tools and plausibility checks mentioned in the present paper can support the daily practice of results release.

Ankara University Stem Cell Institute Interdisciplinary Stem Cells and Regenerative Medicine Ankara Turkey

Association of Clinical Biochemists in Ireland Ireland

Clinical Chemistry Laboratory Spedali Civili Brescia Italy

Clinical Laboratory Hospital Kladno Kladno Czech Republic

Department of Biomedical and Clinical Sciences Luigi Sacco and Research Centre for Metrological Traceability in Laboratory Medicine University of Milan Milano Italy

Department of Clinical Biochemistry Attikon University General Hospital Medical School National and Kapodistrian University of Athens Haidari Greece

Department of Clinical Chemistry University Clinic for Respiratory and Allergic Deseases Golnik Slovenia

Department of Medical Biochemistry Pharmaceutical Faculty University of Belgrade Belgrade Serbia

Dept of Genetics Rare Diseases and Personalized Medicine Rare Diseases and Autoinflammatory Unit CHU Montpellier Montpellier France

Laboratory Medicine Department of Public Health Biomedical Sciences Group University Hospital Leuven Belgium KU Leuven Leuven Belgium

Linko Q Solutions FI 00950 Helsinki Finland

Pôle de Biologie Médicale et Pathologie Site Saint Antoine Paris France

Regional Laboratoriemedicin Sahlgrenska Universitetssjukhuset Trollhättan Göteborg Sweden

Result Laboratory for Clinical Chemistry Amphia Hospital Breda the Netherlands ; Department of Laboratory Medicine Radboud University Medical Centre Nijmegen the Netherlands

Servicio Bioquímica Análisis Clínicos Hospital Universitario Puerta de Hierro Majadahonda Madrid Spain

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